Investigation of the Impact of Smoking Status on Allergen-induced Nasal Airway Inflammation Using a Cat Hair (Felis Domesticus) Extract Nasal Allergen Challenge Model

Exclusion Criteria

• •1. Any chronic medical condition considered by the PI as a contraindication to the allergen challenge study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, bleeding disorder, or chronic thyroid disease.
• •2. Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
• •3. Use of systemic steroid therapy within the preceding 12 months for treatment of an asthma exacerbation.
• •4. Use of inhaled or nasal steroids, cromolyn or leukotriene receptor antagonists (Montelukast or Zafirkulast) within the past month (except for use of cromolyn exclusively prior to exercise).
• •5. Use of allergen immunotherapy.
• •6. Use of daily theophylline within the past month.
• •7. Use of nasal medications that might alter the response to nasal allergen challenge including anti-inflammatory and anti-histamine agents within one week of challenge.
• •8. Inability to withhold inhaled or oral bronchodilator medications for 12 hours prior to allergen challenge.
• •9. Pregnancy or nursing a baby.
• •10. Women of child-bearing age who are not using dependable contraception (such as birth control pills, IUD, estrogen patches) or who are not completely abstinent.
• •11. Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
• •12. Exacerbation of asthma more than 2x/week which would be characteristic of a person with moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
• •13. Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise).
• •14. Viral upper respiratory tract infection within 4 weeks of challenge.
• •15. Any acute infection requiring antibiotics within 4 weeks of challenge.
• •16. Participating in an allergen inhalation study within 2 weeks of this challenge or use of any investigational agent within the last 30 days.
• •17. Use of tricyclic antidepressants or beta-blockers.
• •18. Use of MAO inhibitors or any medications known to interfere with the treatment of anaphylaxis.
• •19. Subjects with a history of immunologic disease or undergoing immune suppression for cancer or other diseases.
• •20. Subjects with acute inflammatory conditions in the nose or paranasal sinuses, such as sinusitis.